Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116

Randomized, Double-blind, Placebo-controlled, Escalating Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered BAY1161116 in Healthy Postmenopausal Women Including Food-effect and Drug-drug-interaction With Itraconazole

This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.

Inclusion Criteria:

• Healthy female postmenopausal subjects
• Age: 45 to 65 years (inclusive)
• Body mass index (BMI) : ≥18 and ≤30 kg/m²
• Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)

Exclusion Criteria:

• Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion,and effect of the study drugs will not be normal
• Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (occasional use of paracetamol or ibuprofen is permissible)
• Any severe disease within the last 4 weeks prior to the first study drug administration
• History of orthostatic hypotension, fainting spells, blackouts
• Any malignant tumor and history thereof
• Any other medical condition which, at the discretion of the investigator, would make study participation unadvisable
• Any clinically relevant finding at the physical- and gynecological examinations
• Allergy, hypersensitivity, or non-allergic drug reactions to any excipient of the IMP or reference/interaction product
• Regular alcohol consumption equivalent to >20 g alcohol per day
• Urine screen positive for any drug or cotinine